Nutritional supplement for use under physiologically stressful conditions

ABSTRACT

A nutritional supplement to be incorporated into the diet of an individual experiencing physiologically stressful conditions is described.

BACKGROUND OF THE INVENTION

1. Field of the Invention

Embodiments of the present invention generally relate to nutritionalsupplements and in particular to nutritional supplements for use underphysiologically stressful conditions.

2. Description of the Related Art

Physiological responses to stressful conditions are generally the same;only the intensity of the response and whether or not any given responsewill be evoked are individual in nature. Acute stressful situations,such as resulting from a trauma, produce a physiological response, afterwhich the body returns to its normal, un-stressful state. When the bodyenters a stressful situation, the sympathetic nervous system invokes afight or flight response. Once the stressful stimuli have been removed,the parasympathetic nervous system returns the body to a normal state.

Chronic stressful conditions, caused by for example a divorce, anunpleasant boss, lack of money, or building a new home, are moreinsidious. The physiological response endures and the body fails toreturn to the baseline state. Being in a continuous state of stress, anindividual will feel unwell, partly because the mechanisms thatordinarily help overcome stress have become exhausted. That is, theparasympathetic nervous system is unable to return the body to a“normal” state.

Symptoms classically seen in a stressful situation include an increasein heart rate, blood pressure, sweating, metabolic rate and peristalticactivity. These symptoms can be alleviated by inducing the body toreturn to its normal resting state.

Thus, there is a need for a nutritional supplement to alleviate or atleast reduce the stress and symptoms associated therewith.

SUMMARY OF THE INVENTION

Embodiments of the present invention related to nutritional supplementsfor users under physiologically stressful conditions. The nutritionalsupplement comprises a source of vitamin A, a source of vitamin E, asource of vitamin D3, source of vitamin C, a source of vitamin B1, asource of vitamin B2, a source of niacin, a source of folic acid, asource of vitamin B6, a source of biotin, a source of pantothenic acid,a source of vitamin B12, and a source of minerals including magnesium,zinc, selenium, chromonium, copper and iron ferronyl.

In one embodiment, the nutritional supplement comprises about 750 IUs ofvitamin A, 125 IUs of vitamin E, about 315 IUs of vitamin D3, about 375mg of vitamin C, about 25 mg of vitamin B1, about 3.4 mg of vitamin B2,about 35 mg of niacin, about 1.25 mg of folic acid, about 35 mg ofvitamin B6, about 75 mcg of biotin, about 5 mg pantothenic acid, about70 mcg of vitamin B12 and various quantities of the minerals listedabove.

In one embodiment, the nutritional supplement can be made in a varietyof forms, such as pharmaceutical compositions (e.g., tablet, powder,suspension, liquid, capsule, and gel), nutritional beverages, puddings,confections (i.e., candy), ice cream, frozen confections and novelties,or non-baked, extruded food products such as bars.

In another embodiment, the ingredients of the nutritional supplement canbe administered separately, just by incorporating certain components(e.g., bitter tasting ones) into a capsule or tablet and the remainingingredients provided as a powder or nutritional bar.

One embodiment of the present invention is a nutritional supplement inthe form of a multi vitamin/mineral with iron tablet, speciallyformulated for prophylactic or therapeutic nutritional supplementationin physiological stressful conditions. In one embodiment, thenutritional supplement can be formulated for single or multiple dailyadministrations. In another embodiment of the present invention, thereis provided one bisected tablet administered daily or as prescribed by aphysician.

An embodiment of the present invention further pertains to therapeuticmethods for managing physiologically stressful conditions in individualsin need thereof. The nutritional supplement can be administered to anindividual to mitigate physiologically stressful conditions, reduce therisk of chronic conditions caused by stress, enhance the immune functionof the individual, improve cognitive performance, promote satiety andweight loss, reduce cortisol, increase brain serotonin and improve mood.

DETAILED DESCRIPTION

It is understood that the embodiments of the present invention are notlimited to the particular methodologies, protocols, solvents andreagents, and the like, described herein as they may vary. It is also tobe understood the terminology used herein is used for the purpose ofdescribing particular embodiments only and not intended to limit thescope of the present invention. It must also be noted that as usedherein and in the appended claims, the singular form “a,” “an” and “the”include the plural reference unless the context clearly dictatesotherwise. Thus, for example, a reference to “a vitamin” is a referenceto one or more vitamins and includes equivalents thereof know to thoseskilled in the art and so forth.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skilledin the art to which this invention belongs. Preferred methods, devicesand materials are described, although any methods and materials similaror equivalent to those described herein could be used in the practice ortesting of the present invention. All references cited herein areincorporated by reference herein in there entirety.

The term “disease state” as used herein, may comprise any state in whichone or more organs or components of an organism malfunction. The termincludes “disease state” may refer to any deterioration of any componentof a body. The term “disease state” may refer to any deficiency of anycompound necessary for the maintenance or function of any component ofany organism. The term “disease state” may refer to any condition inwhich a body contains toxins, produced by microorganisms that infect thebody or by body cells through faulty metabolism or absorbed from anexternal source.

The term “disease states” may be adverse states caused by any diet, anyvirus, or any bacteria. “Disease states” may comprise disordersassociated with pregnant females such as for example, osteomalacia andpreeclampsia and disorders associated with a fetus such as, for example,neurotube defects and various fetal abnormalities. “Disease states” maycomprise any pulmonary disorder such as, for example, bronchitis,bronchiectasis, atelectasis, pneumonia, diseases caused by inorganicdust, diseases caused by organic dust, any pulmonary fibrosis, andpleurisy. “Disease states” may comprise any hematological/oncologicaldisorders such as, for example, anemia, hemophilia, leukemia, lymphoma.

A “disease state” may comprise any cancer such as, for example, breastcancer, lung cancer, prostate cancer, pancreatic cancer, liver cancer,stomach cancer, testicular cancer, ovarian cancer, skin cancer, cancerof the brain, cancer of the mouth, cancer of the throat, and cancer ofthe neck. “Disease states” may comprise any disorder of the immunesystem such as, for example, Acquired Immune Deficiency Syndrome (AIDS),AIDS-related complex, infection by any strain of any HumanImmunodeficiency Virus (HIV), and other viruses and pathogens such asbacteria.

A “disease state” may comprise any cardiovascular disorders such as, forexample, arterial hypertension, orthostatic hypotension,arterioloscierosis, coronary artery disease, cardiomyopathy, anyarrhythmia, any valvular heart disease, endocarditis, pericardialdisease, any cardiac tumor, any aneurism, and any peripheral vasculardisorder. “Disease states” may comprise any hepatic/biliary disorderssuch as, for example, jaundice, hepatic steatosis, fibrosis, cirrhosis,hepatitis, any hepatic granuloma, any liver tumor, cholelithiasis,cholecystitis, and choledocholithiasis.

The term “physiologically stressful state,” as used herein, comprisesany state of an organism in which the organism faces one or morephysiological challenges. A “physiologically stressful state” maycomprise pre-pregnancy, pregnancy, lactation, or conditions in which anorganism faces physiological challenges related to for example, elevatedmetabolic demand, increased plasma volume, or decreased concentrationsof nutrient-binding proteins. A “physiologically stressful state” mayresult from one or more disease states.

The term “subject” as used herein comprises any and all organisms andincludes the term “patient.” “Subject” may refer to a human or any otheranimal. “Subject” may also refer to a fetus.

Embodiments of the present invention relate to a nutritional supplement,which contains active ingredients to relieve an individual in aphysiological stressful condition. One embodiment of the presentinvention assembles clinically proven food-grade nutrients inefficacious doses shown to relieve the symptoms of physiologicalstressful conditions. Specifically, the nutritional supplement comprisesfat-soluble and water-soluble vitamins as well as essential minerals, incertain amounts, to reduce physiological stressful conditions associatedwith the individual as discussed below.

Physiological responses to physiological stressful conditions are thesame regardless of the causation. Under stressful situations, the bodyreleases neurotransmitters (e.g., epinephrine, norepinephrine andserotonin) and cortisol to bring the body back to a non-stressed state.In a chronically stressed situation, the neurotransmitters can becomedepleted and as a result, the lack of serotonin is directly related topoor mood and depression. Cortisol, however, does not get depleted andits continued presence in the body depresses mood. Long-term exposure tocortisol leads to impaired memory, depressed immune function, chronicobesity and development of chronic disease.

The nutritional supplement can be made in a variety of forms such as apharmaceutical composition (e.g., table, powder, suspension, liquid,capsule, and jel), nutritional beverages, puddings, confections (i.e.,candy), ice cream, frozen confections and novelties, or non-bakedextruded food such as bars to assist patients with stressful conditionsand the management thereof. The nutritional supplement can be formulatedinto a snack to be taken as part of a diet or it can be formulated as ameal replacement. For a snack and meal replacement, nutritionalsupplements should provide from about 50 to about 400 kcal per serving.

For purposes of the present invention, an embodiment of the nutritionalsupplement comprises the components described about as a single serving(serving unit), whereby one or a plurality (in one embodiment: two) ofthese supplements is (are) consumed daily. The proportions of these Ningredients are based on about 60 to about 75-gram serving. Thepreferred form of administration is in tablet form but the supplementcould be consumed as a nutritional bar or as a liquid.

In an embodiment, each serving contains 220 kcal and is comprised ofmacro nutrient percentages in concert with the dietary recommendation ofthe American Diabetic Association and American Dietary Association.Other serving sizes are contemplated by the present invention. The totalamount of each ingredient should be appropriately adjusted.

The ingredients that make up the nutritional supplement are described indetail below with regard to their relative role each contributes to thetherapeutic advantages of the present invention.

Vitamin A is a family of fat-soluble compounds that play an importantrole in vision, bone growth, reproduction, cell division, and celldifferentiation (in which a cell becomes part of the brain, muscle,lungs, etc.). Vitamin A helps regulate the immune system, which helpsprevent or fight off infections by making white blood cells that destroyharmful bacteria and viruses.

Vitamin A also may help lymphocytes, a type of white blood cell, fightinfections more effectively. Vitamin A promotes healthy surface liningsof the eyes and the respiratory, urinary, and intestinal tracts. Whenthose linings break down, it becomes easier for bacteria to enter thebody and cause infection. Vitamin A also helps maintain the integrity ofskin and mucous membranes, which also function as a barrier to bacteriaand viruses.

Betacarotene is a powerful antioxidant, protecting the cells against theonslaught of damaging free radicals. Free radicals are unstablemolecules that float freely throughout the body. Free radical damage maybe responsible for a dangerous chain reaction that could possibly resultin chronic diseases. Betacarotene may also be useful to the immunesystem, in preventing some of the effects of ageing, and in thetreatment of acne and other skin disorders.

The remarkable value of Betacarotene is that it will only convert tovitamin A as the body requires it. This controlled conversion ensuresits safety and non-toxicity as a source of vitamin A. The unwantedBetacarotene circulates through the body's blood plasma and is stored inthe tissues. There it may play an invaluable role as an antioxidant,slowing down the ageing process and protecting cells against the harmfulfree radical damage that comes from the environment in the forms ofpollution, cigarette smoke and other toxins. This ‘excess’ Betacarotenemight also be helpful in stimulating the immune system to kill off tumorcells and to attack other viruses and infections.

Vitamin E, a fat-soluble vitamin, is an antioxidant vitamin involved inthe metabolism of all cells. It protects vitamin A and essential fattyacids from oxidation in the body cells and prevents breakdown of bodytissues.

Vitamin D3 is a naturally occurring bodily substance that many believeexert a protective effect in multiple sclerosis—both in the developmentof the disease and in limiting its progression. It is naturally producedin the skin in response to sunlight but is also present in certainfoodstuffs (particularly oily fish). Vitamin D3 is a type of steroidhormone and among other things, a powerful mediator of immune function.

Vitamin D3 is best known for its effect on calcium metabolism. Properlevels are necessary to maintain bone mineral density and serum (blood)calcium levels. This is especially true among the very young where it isused to treat rickets and in combination with vitamin A for thetreatment of osteoporosis in the elderly, particularly post menopausalwomen who are often subject to fractures due to loss of bone density.

In studies, vitamin D3 has been found helpful against autoimmunity forthe down-regulation of Th1 and up-regulation of Th2 cells. It has alsobeen shown to regulate the neurotrophins NGF (Nerve Growth Factor), NT-3(NeuroTrophin 3) and NT-4. In addition, vitamin D3 has also been foundto promote differentiation and cell death in neuroblastoma (brain tumor)cell lines as well as cancers in general.

Vitamin C is a water-soluble, antioxidant vitamin. It is important informing collagen, a protein that gives structure to bones, cartilage,muscle, and blood vessels. Vitamin C also aids in the absorption ofiron, and helps maintain capillaries, bones, and teeth. As awater-soluble antioxidant, vitamin C is in a unique position to“scavenge” aqueous peroxyl radicals before these destructive substanceshave a chance to damage lipids. It works along with vitamin E, afat-soluble antioxidant, and the enzyme glutathione peroxidase to stopfree radical chain reactions. Vitamin C can enhance the body'sresistance to an assortment of diseases, including infectious disordersand many types of cancer. It strengthens and protects the immune systemby stimulating the activity of antibodies and immune system cells suchas phagocytes and neutrophils. Vitamin C contributes to a variety ofother biochemical functions. These include the biosynthesis of the aminoacid carnitine and the catecholamines that regulate the nervous system.It also helps the body to absorb iron and to break down histamine.Although vitamin C is found in every cell, it is especially useful inkey parts of the body. These include the blood, the skin, the nervoussystem, the teeth and bones and glands such as the thymus, adrenals andthyroid.

Vitamin B1, also known as thiamin, helps fuel your body by convertingblood sugar into energy. It keeps the mucous membranes healthy and isessential for nervous system, cardiovascular and muscular function.Vitamin B1 (thiamin) is essential for the metabolism of carbohydrates toproduce energy and for normal nerve and heart function.

Riboflavin is a water-soluble vitamin in the B-complex group. Riboflavin(vitamin B2) works with the other B vitamins. It is important for bodygrowth and red blood cell production and helps in releasing energy fromcarbohydrates. Riboflavin (vitamin B2), as flavin mononucleotide orflavin adenine dinucleotide, acts as an essential coenzyme in manyoxidation-reduction reactions involved with carbohydrate metabolism.Deficiency results in oral, ocular, cutaneous, and genital lesions.

Niacin, vitamin B3 is required for cell respiration, helps in therelease of energy and metabolism of carbohydrates, fats, and proteins,proper circulation and healthy skin, functioning of the nervous system,and normal secretion of bile and stomach fluids. It is used in thesynthesis of sex hormones, treating schizophrenia and other mentalillnesses, and a memory-enhancer. Niacin given in pharmaceutical dosageimproves the blood cholesterol profile, and has been used to clear thebody of organic poisons, such as certain insecticides.

Folic acid is a water-soluble vitamin in the B-complex group. Folic acidworks along with vitamin B12 and vitamin C to help the body digest andutilize proteins and to synthesize new proteins when they are needed. Itis necessary for the production of red blood cells and for the synthesisof DNA. Folic acid also helps with tissue growth and cell function. Inaddition, it helps to increase appetite when needed and stimulates theformation of digestive acids. Folic acid supplements may be used in thetreatment of disorders associated with folic acid deficiency and mayalso be part of the recommended treatment for certain menstrual problemsand leg ulcers.

Vitamin B6 is a water-soluble vitamin that exists in three majorchemical forms: pyridoxine, pyridoxal, and pyridoxamine. It performs awide variety of functions in the body and is essential for good health.For example, vitamin B6 is needed for more than 100 enzymes involved inprotein metabolism. It is also essential for red blood cell metabolism.The nervous and immune systems need vitamin B6 to function efficiently,and it is also needed for the conversion of tryptophan to niacin.

The body needs vitamin B6 to make hemoglobin. Hemoglobin within redblood cells carries oxygen to tissues. vitamin B6 also helps increasethe amount of oxygen carried by hemoglobin. A vitamin B6 deficiency canresult in a form of anemia that is similar to iron deficiency anemia.Vitamin B6 also helps maintain blood glucose (sugar) within a normalrange. When caloric intake is low, the body needs vitamin B6 to helpconvert stored carbohydrate or other nutrients to glucose to maintainnormal blood sugar levels.

Biotin, a water-soluble member of the B-vitamin family, is an essentialnutrient in human nutrition. It is involved in the biosynthesis of fattyacids, gluconeogenesis, energy production, the metabolism of thebranched-chain amino acids (L-leucine, L-isoleucine, L-valine) and thede novo synthesis of purine nucleotides. Research indicates that biotinplays a role in gene expression, both at the transcriptional andtranslational levels, and that it may also play a role in DNAreplication. Biotin is necessary for both metabolism and growth inhumans, particularly with reference to production of fatty acids,antibodies, digestive enzymes, and niacin (vitamin B3) metabolism.

Pantothenic acid, also known as vitamin B5, is essential for a number ofbasic bodily functions, from growth to reproduction. It participates inthe continual breakdown of carbohydrates, fats, and proteins from food,converting them into compounds the body can use. This vitamin alsoproduces numerous enzymes and helps maintain precise communicationbetween the central nervous system and the brain. Pantothenic acid comesin two forms: calcium pantothenate and pantethine. Calcium pantothenateis widely used for treating ailments from stress to heartburn, whilepantethine is mainly recommended for lowering blood cholesterol levelsin those who don't respond to other natural treatments.

Vitamin B12, a water-soluble vitamin, is also called cobalamin becauseit contains the metal cobalt. This vitamin helps maintain healthy nervecells and red blood cells. It is also needed to help make DNA, thegenetic material in all cells.

Magnesium is the fourth most abundant mineral in the body and isessential to good health. Approximately 50% of total body of magnesiumis found in the bone. The other half is found predominantly inside cellsof body tissues and organs. Only 1% of magnesium is found in blood, butthe body works very hard to keep blood levels of magnesium constant.Magnesium is needed for more than 300 biochemical reactions in the body.It helps maintain normal muscle and nerve function, keeps heart rhythmsteady, supports a healthy immune system, and keeps bones strong.Magnesium also helps regulate blood sugar levels, promotes normal bloodpressure, and is known to be involved in energy metabolism and proteinsynthesis. Magnesium may play a role in preventing and managingdisorders such as hypertension, cardiovascular disease, and diabetes.

Zinc is vital for the healthy working of many of the body's systems.Zinc plays a crucial role in growth and cell division where it isrequired for protein and DNA synthesis, in insulin activity, in themetabolism of the ovaries and testes, and in liver function. As acomponent of many enzymes, zinc is involved in the metabolism ofproteins, carbohydrates, lipids and energy. Zinc helps with the healingof wounds and is a vital component of many enzyme reactions. It is alsoimportant for healthy skin and is essential for a healthy immune systemand resistance to infection.

Selenium is a trace mineral essential to good health. Selenium isincorporated into proteins to make selenoproteins, which are importantantioxidant enzymes. The antioxidant properties of selenoproteins helpprevent cellular damage from free radicals that may contribute to thedevelopment of chronic diseases such as cancer and heart disease. Otherselenoproteins help regulate thyroid function and play a role in theimmune system.

Chromium is a mineral required in small quantities by the body. Itenables insulin to function normally and helps the body metabolizecarbohydrates and fats. Picolinate, a by-product of the amino acidtryptophan, is paired with chromium in supplements because it helps thebody absorb chromium more efficiently.

Copper is needed for normal growth and health. Copper is also needed tohelp the body use iron. It is also important for nerve function, bonegrowth, and to help the body use sugar.

Iron is an essential nutrient that carries oxygen and forms part of theoxygen-carrying proteins, hemoglobin in red blood cells and myoglobin inmuscle. Iron is also a structural component at the catalytic site of alarge number of enzymes covering a wide array of diverse metabolicfunctions. These include neurotransmitter synthesis and function,phagocyte antimicrobial activity, hepatic detoxification systems, andsynthesis of DNA, collagen and bile acids.

Alpha-lipoic acid, also known as thioctic acid, is a disulfide compoundthat is a cofactor in vital energy-producing reactions in the body. Itis also a potent biological antioxidant in both the fatty and wateryregions of cells. Alpha-lipoic acid also plays an important role in thesynergism of antioxidants, recycling and extending the metaboliclifespan of vitamin C, glutathione, coenzyme Q10, and vitamin E.

Lutein is a member of the carotenoid family, a family best known forbetacarotene. Lutein is a natural fat-soluble yellowish pigment found inthe macula of the human retina, as well as the human crystalline lens.It is thought to play a role in protection against age-related maculardegeneration (ARMD) and age-related cataract formation. Lutein may alsobe protective against some forms of cancer.

Lycopene is a member of the carotenoid family of chemical substances.Lycopene is a natural fat-soluble pigment and antioxidant that may bebeneficial in treating certain disorders, such as prostate cancer andother cancers, coronary heart disease, exercise-induced asthma, maculardegeneration, sunburn, atherosclerosis, high cholesterol, and high bloodpressure associated with pregnancy.

In one embodiment, the preferred source of vitamin A is betacarotene,the preferred source of vitamin E is d-alphasuccinate, the preferredsource of vitamin D3 is cholecalciferol.

A good source of vitamin C is ascorbic acid. A good source of vitamin B1is thiamine mono-nitrate, a source of vitamin B2 is riboflavin, a goodsource of niacin is niacinamide, and a good source of vitamin B6 ispyridoxine HCL. A good source of vitamin B12 is cyanocobalamin. A goodsource of selenium is selenomethionine. A good source of chromium ispicolinate. A good course of copper is gluconate.

The nutritional supplement can also contain other ingredients such asone or a combination of other vitamins, minerals, antioxidants, fiber,herbs and other nutritional supplements. For example but in no waylimiting, other ingredients may include croscarmelloose sodium, calciumphosphate, microcrystalline cellulose, steraric acid, magnesiumstearate, silica, phovodione, hydroxypropyl methylcelluose, titaniumdioxide, FD&C Yellow # 5, FD&C Blue #1.

The amount of the other ingredients per unit serving are a matter ofdesign and will depend upon the total number of unit servings of thenutritional supplement daily administered to the patient. The totalamount of other ingredients will also depend, in part, upon thecondition of the patient. Preferably the amount of other ingredientswill be a fraction or multiplier of the recommended daily allowance(RDA) or RDI (reference daily intake) amounts. For example, nutritionalsupplements can comprise 50 percent RDI of vitamins and minerals perunit dosage and the patient will consume two units per day.

Flavors, coloring agents, spices, nuts and the like can be incorporatedinto the product. Flavorings can be in the form of flavored extracts,volatile oils, chocolate flavorings (e.g., non-caffeinated cocoa orchocolate or chocolate substitute such as carob), peanut butterflavoring, cookie crumbs, crisp rice, vanilla or any commerciallyavailable flavoring. Flavoring can be protected with mixed tocopherols.

Examples of useful flavorings include but are not limited to pure aniseextract, imitation banana extract, imitation cherry extract, chocolateextract, pure lemon extract, pure orange extract, pure peppermintextract, imitation pineapple extract, imitation rum extract, imitationstrawberry extract, or pure vanilla extract or volatile oils, such asbalm oil, bay oil or bergamots oil, cedar-wood oil, cherry oil, walnutoil, cinnamon oil, clove oil, or peppermint oil; peanut butter,chocolate flavoring, vanilla cookie crumb, butterscotch or toffee.

In an embodiment, nutritional supplement contains berry or other fruitflavors. The food compositions may further be coated, for example with ayogurt coating, if it is produced as a bar.

Emulsifiers may be added for stability of the final product. Examples ofsuitable emulsifiers include, but are not limited to, lecithin (e.g.,from egg or soy), and/or mono-n dye-glycerides. Other emulsifiers arereadily apparent to the skilled artesian and selection of suitableemulsifiers will depend, in part, on the formulation and finalnutritional supplement.

Preservatives may also be added to the nutritional supplement to extendproduct shelf life. Preferably, preservatives such as potassium sorbate,sodium sorbate, potassium benzonate, sodium benzonate or calciumdisodium EDTA are used.

The nutritional supplements of embodiments of the present invention maybe formulated using any pharmaceutically acceptable forms of thevitamins, minerals and other nutrients discussed above, including theirsalts. They may be formulated into capsules, tablets, powders,suspensions, jells or liquids optionally comprising at physiologicallyacceptable carrier such as but not limited to water, milk, juice, sodas,starch, vegetable oils, salt solutions, hydroxymethyl cellulose,carbohydrates.

In an embodiment, bio-nutritional supplements may be formulated as atablet. The nutritional supplements of this invention may be formulatedwith other foods or liquids to provide pre-measured supplemental foods,such as a single serving bar or beverage, for example. To manufacturesuch a beverage, the ingredients are dried and made readily soluble inwater and other consumable liquids as described above.

Use of the Nutritional Supplement for Physiologically StressfulConditions.

Several of the complex actions initiated by a stressful condition aredependent on a constant supply of certain nutrients. Lack of thesenutrients often causes poor adaptation to the stressful condition and afailure to return to homeostasis. The most comprehensive work on thissubject is the report from the Committee on Military Nutrition Researchof the Institute of Medicine in response to the Armed Forces request fora list of nutrients that will enhance performance during stressfulconditions. (Marriott BM (ed.), Food Components to Enhance Performance,Washington, D.C.: National Academy Press (1994): Committee on MilitaryNutrition and Research, Conclusions and Recommendations, in: MarriottBN. Food Components to Enhance Performance, Washington, D.C.: NationalAcademy Press, 47-61, 1994)).

The active ingredients of a nutritional supplement of the presentinvention, as discussed in detail above, work to relieve stressfulconditions and alter the mood.

Long-term administration of the nutritional supplements of the presentinvention may aid in the reduction of health risks associated withchronic stress, such as diminished mental and physical performance,dampened immune function, depression, hyper lididemia, cardiovasculardisease, hypertension, obesity and diabetes. Regulation of serotonin andcortisol levels using the nutritional supplement in the presentinvention may be instrumental in reducing some of the side effects ofstress. The composition and dietary nutritional supplements of thepresent invention are, in one embodiment, orally administered daily.Based on the serving size of about 60 grams to about 75 grams perserving, the recommended dosage is twice daily. For example, thesupplement is in the form of a tablet and the patient would consume onein the morning and one mid to late afternoon, to modulate stress andmood, which can be impaired by foods consumed at lunch. The recommendeddaily amounts of each ingredient, as described above, serve as aguideline for formulating the dietary supplements of this presentinvention. The actual amounts of each ingredient per unit dosage willdepend on the number of units daily administered to the individual inneed thereof. This is a matter of product design and is well within theskill of the dietary supplement formulator.

The ingredients can be administered in a single formulation or they canbe separately administered. For example, it may be desirable toadminister bitter tasting ingredients in the form that masks theirtastes (e.g., capsule or pill form) rather than incorporating them intothe nutritional composition it self (e.g., powder or bar). Thus, anembodiment of the present invention also provides a pharmaceutical packor one or more containers filled with one or more of the ingredients ofthe nutritional compositions of the invention (e.g., nutritionalsupplement in the form of a powder and tablets).

While the invention has been particularly shown and described withreference to embodiments thereof, it will be understood by those skilledin the art that various changes in form and details may be made thereinwithout departing from the scope of the present invention encompassed bythe appended claims.

1. A composition, comprising: about 0 to 1500 IUs of vitamin A, about 0to 250 IUs of vitamin E, about 0 to 630 IUs of vitamin D3, about 0 to750 IUs of vitamin C, about 0 to 50 mg of vitamin B1, about 0 to 6.8 mgof riboflavin, about 0 to 70 mg of niacin, about 0 to 2.5 mg of folicacid, about 0 to 70 mg of vitamin B6, about 0 to 75 mcg of biotin, about0 to 10 mg pantothenic acid, about 0 to 140 mcg of vitamin B12, about 0to 70 mg of magnesium, about 0 to 70 mg of zinc oxide, about 0 to 250mcg of selenium, about 0 to 300 mg of chromium, about 0 to 2 mg ofcopper, about 0 to 26 mg of iron, about 0 to 20 mg of alpha lipoic acid,about 0 to 14 mg of lutein 5 percent, and about 0 to 5 mg of lycopene 5percent in a pharmaceutically acceptable single dosage formulation.
 2. Acomposition, comprising: about 750 IUs of vitamin A, about 125 IUs ofvitamin E, about 315 IUs of vitamin D3, about 375 mg of vitamin C, about25 mg of vitamin B1, about 3.4 mg of riboflavin, about 35 mg of niacin,about 1.25 mg of folic acid, about 35 mg of vitamin B6, about 75 mcg ofbiotin, about 5 mg of pantothenic acid, about 70 mcg of vitamin B12,about 35 mg of magnesium, about 35 mg of zinc, about 125 mcg ofselenium, about 150 mcg of chromium, about 1 mg of copper, about 13 mgof iron, about 10 mg of alpha lipoic acid, about 7 mg of lutein 5percent and about 2.5 mg of lycopene 5 percent in a pharmaceuticallyacceptable single dosage formulation.
 3. The composition of claim 1,wherein the single dosage formulation is selected from the groupconsisting of a pill, a tablet, a caplet, a capsule, a chewable tablet,a quick dissolve tablet, an effervescent tablet, a hard gelatin capsule,and a soft gelatin capsule.
 4. The composition of claim 3, wherein thesingle dosage formulation comprises an enteric coating.
 5. Thecomposition of claim 2, wherein the single dosage formulation isselected from the group consisting of a pill, a tablet, a caplet, acapsule, a chewable tablet, a quick dissolve tablet, an effervescenttablet, a hard gelatin capsule, and a soft gelatin capsule.
 6. Thecomposition of claim 5, wherein the single dosage formulation comprisesan enteric coating.
 7. The composition of claim 1, wherein the singledosage formulation comprises a liquid suspension.
 8. The composition ofclaim 1, wherein the single dosage formulation comprises a food product.9. The composition of claim 2, wherein the single dosage formulationcomprises a liquid suspension.
 10. The composition of claim 2, whereinthe single dosage formulation comprises a food product.
 11. A methodcomprising the step of administering to an individual a compositioncomprising about 0 to 1500 IUs of vitamin A, about 0 to 250 IUs ofvitamin E, about 0 to 630 IUs of vitamin D3, about 0 to 750 IUs ofvitamin C, about 0 to 50 mg of vitamin B1, about 0 to 6.8 mg ofriboflavin, about 0 to 70 mg of niacin, about 0 to 2.5 mg of folic acid,about 0 to 70 mg of vitamin B6, about 0 to 75 mcg of biotin, about 0 to10 mg pantothenic acid, about 0 to 140 mcg of vitamin B12, about 0 to 70mg of magnesium, about 0 to 70 mg of zinc oxide, about 0 to 250 mcg ofselenium, about 0 to 300 mg of chromium, about 0 to 2 mg of copper,about 0 to 26 mg of iron, about 0 to 20 mg of alpha lipoic acid, about 0to 14 mg of lutein 5 percent, and about 0 to 5 mg of lycopene 5 percent.12. A method comprising the step of administering to an individual acomposition comprising about 750 IUs of vitamin A, about 125 IUs ofvitamin E, about 315 IUs of vitamin D3, about 375 mg of vitamin C, about25 mg of vitamin B1, about 3.4 mg of riboflavin, about 35 mg of niacin,about 1.25 mg of folic acid, about 35 mg of vitamin B6, about 75 mcg ofbiotin, about 5 mg of pantothenic acid, about 70 mcg of vitamin B12,about 35 mg of magnesium, about 35 mg of zinc, about 125 mcg ofselenium, about 150 mcg of chromium, about 1 mg of copper, about 13 mgof iron, about 10 mg of alpha lipoic acid, about 7 mg of lutein 5percent and about 2.5 mg of lycopene 5 percent.